Difficult To Predict Revenue Potential Of Zejula’s Approval: Dishman Pharma
What Is Zejula?
Niraparib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Niraparib is used as a "maintenance" treatment to keep certain types of cancer from coming back. This includes cancers of the ovary, fallopian tube, or peritoneum (the membrane that lines the inside of your abdomen and covers some of your internal organs).
Niraparib is given after you have received chemotherapy (with cisplatin, oxaliplatin, carboplatin, or similar) and your cancer has responded to that medicine.
Niraparib may also be used for purposes not listed in this medication guide.
You should not use niraparib if you are pregnant.Avoid pregnancy for at least 6 months after you stop using this medicine.
You should not breast-feed while using this medicine and for at least 1 month after your last dose.
You should not use niraparib if you are allergic to it.
To make sure niraparib is safe for you, tell your doctor if you have:
- heart disease;
- high blood pressure; or
- liver or kidney disease.
Do not use niraparib if you are pregnant.It could harm the unborn baby or cause a miscarriage. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
You may need to have a negative pregnancy test before starting this treatment.
This medicine may affect fertility (the ability to have children)in men.Talk with your doctor about your individual risk.
It is not known whether niraparib passes into breast milk or if it could harm a nursing baby.You should not breast-feed while using this medicine and for at least 1 month after your last dose.
Zejula Side Effects
Get emergency medical help if you havesigns of an allergic reaction:hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- pounding heartbeats or fluttering in your chest;
- sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
- pain or burning when you urinate;
- increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
- low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed; or
- signs of a bone marrow disorder--fever, weakness, tiredness, feeling short of breath, weight loss, blood in your urine or stools.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- indigestion, stomach pain, loss of appetite, nausea, vomiting;
- constipation, diarrhea;
- irregular heartbeats, feeling short of breath;
- abnormal liver function tests;
- dry mouth, mouth sores;
- altered sense of taste;
- back pain, muscle or joint pain;
- feeling tired;
- headache, dizziness, anxiety;
- sleep problems (insomnia);
- sore throat; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Other drugs may interact with niraparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
You should start taking niraparib no longer than 8 weeks after your most recent chemotherapy treatment with a platinum medicine (cisplatin, oxaliplatin, carboplatin).
You may take niraparib with or without food. Take the medicine at the same time each day.
Niraparib is usually taken once a day until your body no longer responds to the medication.
Niraparib may be taken at bedtime it upsets your stomach.
Do not crush, chew, break, or open a niraparib capsule. Swallow it whole.
If you vomit shortly after taking a niraparib capsule, do not take another one. Wait until your next scheduled dose and take the regular amount of medicine at that time.
Niraparib can lower blood cells that help your body fight infections and help your blood to clot.Your blood will need to be tested often.Your cancer treatments may be delayed based on the results of these tests.
Your blood pressure and heart rate will also need to be checked often.
Store at room temperature away from moisture and heat.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.Do nottake extra medicine to make up the missed dose.
Copyright 1996-2019 Cerner Multum, Inc.
Video: Ovarian Cancer: Optimizing Treatment With Niraparib
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